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<ep-patent-document id="EP91115564B1" file="EP91115564NWB1.xml" lang="en" country="EP" doc-number="0476540" kind="B1" date-publ="19960131" status="n" dtd-version="ep-patent-document-v1-1">
<SDOBI lang="en"><B000><eptags><B001EP>AT..CHDE..ESFRGB..ITLI............................</B001EP><B005EP>R</B005EP></eptags></B000><B100><B110>0476540</B110><B120><B121>EUROPEAN PATENT SPECIFICATION</B121></B120><B130>B1</B130><B140><date>19960131</date></B140><B190>EP</B190></B100><B200><B210>91115564.6</B210><B220><date>19910913</date></B220><B240><B241><date>19920924</date></B241><B242><date>19940930</date></B242></B240><B250>en</B250><B251EP>en</B251EP><B260>en</B260></B200><B300><B310>584457</B310><B320><date>19900918</date></B320><B330><ctry>US</ctry></B330></B300><B400><B405><date>19960131</date><bnum>199605</bnum></B405><B430><date>19920325</date><bnum>199213</bnum></B430><B450><date>19960131</date><bnum>199605</bnum></B450><B451EP><date>19950320</date></B451EP></B400><B500><B510><B516>6</B516><B511> 6A 61B  17/00   A</B511><B512> 6A 61B  17/11   B</B512></B510><B540><B541>de</B541><B542>Vorrichtung zum Festhalten von rohrförmigen Körpergängen während Chirurgie</B542><B541>en</B541><B542>Device for holding tubular body ducts during surgery</B542><B541>fr</B541><B542>Dispositif pour tenir des conduits corporels tubulaires en chirurgie</B542></B540><B560><B561><text>EP-A- 0 032 826</text></B561><B561><text>GB-A- 1 546 172</text></B561><B561><text>US-A- 3 568 677</text></B561><B561><text>US-A- 4 651 733</text></B561><B561><text>US-A- 4 762 127</text></B561><B561><text>US-A- 4 854 318</text></B561><B565EP><date>19911129</date></B565EP></B560><B590><B598>2</B598></B590></B500><B700><B720><B721><snm>Jain, Krishna M.</snm><adr><str>Suite 110,
1535 Gull Road</str><city>Kalamazoo,
Michigan 49001</city><ctry>US</ctry></adr></B721></B720><B730><B731><snm>Jain, Krishna M.</snm><iid>01411960</iid><irf>J 8101 EP</irf><adr><str>Suite 110,
1535 Gull Road</str><city>Kalamazoo,
Michigan 49001</city><ctry>US</ctry></adr></B731></B730><B740><B741><snm>Schaumburg, Thoenes &amp; Thurn</snm><iid>00100351</iid><adr><str>Mauerkircherstrasse 31</str><city>D-81679 München</city><ctry>DE</ctry></adr></B741></B740></B700><B800><B840><ctry>AT</ctry><ctry>CH</ctry><ctry>DE</ctry><ctry>ES</ctry><ctry>FR</ctry><ctry>GB</ctry><ctry>IT</ctry><ctry>LI</ctry></B840><B880><date>19920325</date><bnum>199213</bnum></B880></B800></SDOBI><!-- EPO <DP n="1"> -->
<description id="desc" lang="en">
<p id="p0001" num="0001">The invention relates generally to medical devices utilized during surgical suturing, specifically, the art of anastomosis. In particular, the invention relates to a device according to the preamble of claim 1. A device of this kind is described in GB-A-1 546 172.</p>
<p id="p0002" num="0002">When performing heart surgery, and other surgery involving blood vessels and other body ducts, the job of anastomosing one vessel to another is normally performed by stitching edges of blood vessel openings together. The need for satisfactorily holding adjacent blood vessels during anastomosis is well recognized, and various solutions have been developed for meeting the need.</p>
<p id="p0003" num="0003">During vein bypass graft surgery, for example, forceps are commonly used to hold and suspend the slanted or beveled open end (fish mouth opening) of a vein in close proximity to the opening on the wall of the aorta while sutures are being taken. However, the forceps can easily slip from its position during the anastomosis. Moreover, the inner wall of the vein is very susceptible to damage due to the holding or stretching of the vein by the forceps. Yet further, the vein has a tendency to collapse which only increases the difficulty in suturing the graft to the aorta.</p>
<p id="p0004" num="0004">Another solution is disclosed in US-A-4 651 733. This device is an elongated rod having a holder on one end, a shank portion in the middle, and a prong on the other end. The prong has a sharply pointed hook extending laterally, and preferably in a rearwardly direction, therefrom. The prong is inserted into the open end of a blood vessel until the hook reaches the distal end of the vessel. The hook pierces the vessel wall to lock the vessel onto the prong whereupon the device<!-- EPO <DP n="2"> --> "holds" the blood vessel in the desired position at the outset of the anastomosis.</p>
<p id="p0005" num="0005">The problem to be solved by the invention is to provide a means of holding a tubular body duct such as a blood vessel during surgery without piercing the wall of the duct, and without placing unnecessary stresses on the interior wall of the duct.</p>
<p id="p0006" num="0006">The invention solves this problem by the features of claim 1. Advantageous further developments are described in the dependent claims.<!-- EPO <DP n="3"> --></p>
<p id="p0007" num="0007">According to the invention, a holding device is provided for use during surgical procedures involving a flexible, expandable tubular body duct. The device comprises an elongated rod having a shank portion and a terminal portion connected to the shank portion. The shank portion is longer than the terminal portion and the terminal portion is angularly disposed relative to the shank portion so that it is not colinear therewith. The terminal portion has a bulbous section, and the outer surface of the terminal portion is free of discontinuities. The bulbous section has a cross-sectional dimension slightly less than the cross-sectional dimension of the unexpanded tubular body duct.</p>
<p id="p0008" num="0008">Preferably, the terminal portion has a terminus and the bulbous section is located at the terminus.</p>
<p id="p0009" num="0009">In another aspect of the invention, the rod is made of plastic, and the shank portion will have means for gripping the rod.</p>
<p id="p0010" num="0010">The shank portion and terminal portion can be integrally formed so that the elongated rod is a unitary structure.</p>
<p id="p0011" num="0011">The invention will now be described with reference to the following drawings in which:
<ul id="ul0001" list-style="none" compact="compact">
<li>FIG. 1 is an isometric view of a blood vessel holding device of the invention;<!-- EPO <DP n="4"> --></li>
<li>FIG. 2 is a partial cross-sectional view of the holding device in use with a blood vessel; and</li>
<li>FIG. 3 illustrates a suturing method employing the device of this invention.</li>
</ul></p>
<p id="p0012" num="0012">Referring to FIG. 1, a holding device 10 for use in surgical procedures involving tubular body ducts is illustrated. The device 10 is particularly adapted for use in holding flexible, expandable tubular body ducts such as blood vessels during anastomosis. The device 10, according to the invention, comprises an elongated body or rod 12 having a substantially straight, cylindrical shank portion 14 and a terminal portion 16 extending from the shank portion.</p>
<p id="p0013" num="0013">The terminal portion 16 extends at an angle with the shank portion 14 as illustrated in FIG. 1, with the shank portion 14 being longer than the terminal portion 16, thereby providing for convenient manipulation of the device.<!-- EPO <DP n="5"> --> Preferably, the terminal portion 16 will extend at an angle of approximately 20 degrees relative to the axis of the shank portion 14. The device 10 typically has an overall length of less than eight inches. Preferably, the device will be formed of a lightweight, substantially rigid material such as plastic, although other materials such as noncorrosive metals are acceptable.</p>
<p id="p0014" num="0014">At the terminus 18 of the terminal portion 16 is a bulbous section 20. The bulbous section 20 has a cross section noticeably larger than the cross section of the terminal portion 16 and the shank 14. Further, the bulbous section 20 has a smooth, rounded exterior surface. The outer surface of the bulbous section 20 and the terminal portion 16 is free of discontinuities.<!-- EPO <DP n="6"> --></p>
<p id="p0015" num="0015">FIG. 2 shows a partial cross-sectional, longitudinal view of the device 10 in use. It will be seen that the bulbous section 20 of the terminus 18 is inserted into the end 22 of a blood vessel 24. Most tubular body ducts, and blood vessels in particular, are flexible and subject to collapse. The smooth surface of the holding device 10, and particularly the bulbous section 20 on the terminal portion 16, permits the device 10 to be inserted into the open end 22 of the blood vessel 24. The cross-sectional dimension of the bulbous section 20 is only slightly less than the diameter of the unexpanded blood vessel 24, and the bulbous section itself has no surface discontinuities. The bulbous section 20 is easily received by the walls of the blood vessel 24, thus maintaining the vessel open. Preferably, about one inch of the terminal portion 16 is inserted into the vessel 24. A tie 25 is placed around the blood vessel 24 and the terminal portion 16 to reduce the diameter of the blood vessel 24 to less than the cross-sectional dimension of the bulbous section 20. The vessel walls simultaneously grip the bulbous portion. Thus, the blood vessel 24 is secured onto the holding device 10. With the holding device thus secured, the shank portion 14 may be grasped and the end 22 of the blood vessel 24 may be manipulated into a position adjacent an adjoining body tissue to be sutured thereto. To facilitate grasping the shank 14, the outer surface thereof may be rough and knurled or coated with a high-friction material.</p>
<p id="p0016" num="0016">FIG. 3 illustrates an end-to-side technique of anastomosis employing a holding device according to the invention. The device 10 is shown inserted into an opening 26 in the end of a vein 24. The opening 26 is disposed adjacent and in proximate facing relationship with respect<!-- EPO <DP n="7"> --> to a complementary opening 28 in the wall of an adjacent blood vessel 30. As is conventional in anastomosis, the openings 26, 28 are oval, and the direction of the oval 28 relative to the axis of a blood vessel depends upon the direction of approach of the vessel 24 with respect to the vessel 30. The bulbous portion 20 in the opening 26 prevents collapse of the opening during the anastomosis procedure. The holder 10 retains the opening 26 in proximate position with respect to the opening 28 until sutures 32, taken by means of attached needles 34, can support the opening 26 in the proximate position. When enough stitches have been taken, for example along slightly more than one-half of the circumference of the opening, the tie 25 is released, and the holder 10 may be removed from the openings 26, 28, whereupon the existing sutures may be tightened, and the suturing completed by taking additional stitches until the vessel 24 is secured to the vessel 30.</p>
</description><!-- EPO <DP n="8"> -->
<claims id="claims01" lang="en">
<claim id="c-en-01-0001" num="0001">
<claim-text>A device (10) for vascular surgery involving a vein (24), said device comprising an elongated rigid rod (12) having a shank portion (14), and a terminal portion (16) connected to the shank portion (14), said terminal portion (16) having a bulbous section (20) spaced from the shank portion (14), the outer surface of the terminal portion (16) being free of discontinuities, and the bulbous section (20) having a cross-sectional dimension so that the terminal portion (16) can be received within the vein (24), <b>characterized</b> in that the terminal portion (16) is not colinear with the shank portion (14) and that the shank portion (14) is longer than the terminal portion (16) and the cross-sectional dimension of the bulbous section (20) is slightly less than the cross sectional dimension of the unexpanded vein (24) so that for holding the vein (24) during surgery the bulbous section (20) can resist withdrawal therefrom when the diameter of the vein (24) between the bulbous section (20) and the shank portion (14) is reduced.</claim-text></claim>
<claim id="c-en-01-0002" num="0002">
<claim-text>A device according to claim 1, wherein the terminal portion (16) has a terminus (18) and the bulbous section (20) is located at the terminus.</claim-text></claim>
<claim id="c-en-01-0003" num="0003">
<claim-text>A device according to claim 1 or 2, wherein the rod (12) is made of plastic.</claim-text></claim>
<claim id="c-en-01-0004" num="0004">
<claim-text>A device according to any one of claims 1 to 3, wherein the shank portion (14) outer surface has friction enhancing means for gripping the rod (12).<!-- EPO <DP n="9"> --></claim-text></claim>
<claim id="c-en-01-0005" num="0005">
<claim-text>A device according to any one of claims 1 to 4, wherein the shank portion (14) and the terminal portion (16) are formed in one piece.</claim-text></claim>
</claims><!-- EPO <DP n="10"> -->
<claims id="claims02" lang="de">
<claim id="c-de-01-0001" num="0001">
<claim-text>Ein Gerät (10) für den gefäßchirurgischen Eingriff an einer Vene (24), umfassend einen länglichen starren Stab (12) mit einem Schaftbereich (14) und einem mit dem Schaftbereich (14) verbundenen Endbereich (16), der einen von dem Schaftbereich (14) beabstandeten bauchigen Abschnitt (20) hat, wobei die Außenfläche des Endbereichs frei von Unterbrechungen ist und wobei der bauchige Abschnitt im Querschnitt so bemessen ist, daß der Endbereich (16) in der Vene (24) aufgenommen werden kann, <u>dadurch gekennzeichnet</u>, daß der Endbereich (16) nicht kollinear mit dem Schaftbereich (14) verläuft und daß der Schaftbereich (14) länger als der Endbereich (16) ist und die Querschnittsgröße des bauchigen Abschnitts (20) etwas kleiner ist als die Querschnittsgröße einer nichtgedehnten Vene (24), so daß sich der bauchige Abschnitt (20) zum Halten der Vene während des chirurgischen Eingriffs nicht aus der Vene zurückziehen kann, wenn der Durchmesser der Vene (24) zwischen dem bauchigen Abschnitt (20) und dem Schaftbereich (14) verringert ist.</claim-text></claim>
<claim id="c-de-01-0002" num="0002">
<claim-text>Gerät nach Anspruch 1, bei welchem der Endbereich (16) einen Endpunkt (18) hat und der bauchige Abschnitt (20) an dem Endpunkt liegt.</claim-text></claim>
<claim id="c-de-01-0003" num="0003">
<claim-text>Gerät nach Anspruch 1 oder 2, bei welchem der Stab (12) aus Kunststoff hergestellt ist.</claim-text></claim>
<claim id="c-de-01-0004" num="0004">
<claim-text>Gerät nach einem der Ansprüche 1 bis 3, bei welchem die Außenfläche des Schaftbereichs (14) mit einem die Reibung vergrößernden Mittel zum Greifen des Stabes (12) versehen ist.</claim-text></claim>
<claim id="c-de-01-0005" num="0005">
<claim-text>Gerät nach einem der Ansprüche 1 bis 4, bei welchem der Schaftbereich (14) und der Endbereich (16) einstückig ausgebildet sind.</claim-text></claim>
</claims><!-- EPO <DP n="11"> -->
<claims id="claims03" lang="fr">
<claim id="c-fr-01-0001" num="0001">
<claim-text>Dispositif (10) pour chirurgie vasculaire impliquant une veine (24), ledit dispositif comportant une tige rigide allongée (12) ayant une partie de manche (14) et une partie terminale (16) reliée à la partie de manche (14), ladite partie terminale (16) ayant une section bulbeuse (20) espacée de la partie de manche (14), la surface extérieure de la partie terminale (16) ne présentant pas de discontinuités, et la section bulbeuse (20) ayant une dimension en coupe transversale telle que la partie terminale (16) peut être reçue à l'intérieur de la veine (24), caractérisé en ce que la partie terminale (16) n'est pas colinéaire avec la partie de manche (14), et en ce que la partie de manche (14) est plus longue que la partie terminale (16) et la dimension en coupe transversale de la section bulbeuse (20) est légèrement inférieure à la dimension en coupe transversale de la veine (24) non expansée afin que, pour maintenir la veine (24) pendant une intervention chirurgicale, la section bulbeuse (20) puisse résister à son retrait de la veine lorsque le diamètre de la veine (24) entre la section bulbeuse (20) et la partie de manche (14) est réduit.</claim-text></claim>
<claim id="c-fr-01-0002" num="0002">
<claim-text>Dispositif selon la revendication 1, dans lequel la partie terminale (16) présente un bout (18) et la section bulbeuse (20) est située au bout.</claim-text></claim>
<claim id="c-fr-01-0003" num="0003">
<claim-text>Dispositif selon la revendication 1 ou 2, dans lequel la tige (12) est réalisée en matière plastique.</claim-text></claim>
<claim id="c-fr-01-0004" num="0004">
<claim-text>Dispositif selon l'une quelconque des revendications 1 à 3, dans lequel la surface extérieure de la partie de manche (14) comporte des moyens d'accroissement de frottement pour la prise de la tige (12).</claim-text></claim>
<claim id="c-fr-01-0005" num="0005">
<claim-text>Dispositif selon l'une quelconque des revendications 1 à 4, dans lequel la partie de manche (14) et la partie terminale (16) sont formées en une pièce.</claim-text></claim>
</claims><!-- EPO <DP n="12"> -->
<drawings id="draw" lang="en">
<figure id="f0001" num=""><img id="if0001" file="imgf0001.tif" wi="156" he="245" img-content="drawing" img-format="tif"/></figure>
</drawings>
</ep-patent-document>
